New Amsterdam Pharma’s obicetrapib, a novel cholesterol-lowering therapy, has demonstrated significant efficacy in reducing low-density lipoprotein cholesterol (LDL-C) in the Phase III BROADWAY trial. This positive outcome positions the company to seek regulatory approval for the treatment of adults with atherosclerotic cardiovascular disease (ASCVD).
The BROADWAY trial (NCT05142722) evaluated obicetrapib in patients with ASCVD who were unable to achieve optimal LDL-C levels despite receiving standard lipid-lowering therapies. The primary endpoint was the percentage change in LDL-C from baseline to day 84.
Obicetrapib significantly outperformed placebo, achieving a mean LDL-C reduction of 36.3% at day 84 and a sustained reduction of 41.5% at day 365. Beyond LDL-C, the therapy also demonstrated reductions in other key lipid biomarkers, including non-HDL-C, lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB). Furthermore, the trial indicated improvements in high-density lipoprotein cholesterol (HDL-C). These comprehensive lipid-lowering effects suggest a potentially powerful new tool in managing cardiovascular risk.
Importantly, obicetrapib exhibited a favorable safety and tolerability profile, exceeding initial expectations. The company reported a notable difference in major adverse cardiovascular events (MACE) between the obicetrapib and placebo groups after one year of treatment, hinting at potential benefits beyond LDL-C lowering. However, further analysis is required to confirm these findings.
Following the announcement of the positive results, New Amsterdam Pharma’s stock price surged by 38.4%, reflecting investor confidence in the drug’s potential. The company currently holds a market capitalization of $2.24 billion.
The 52-week global Phase III trial enrolled patients receiving 10mg of obicetrapib or placebo once daily. The robust design and positive outcomes underscore the potential of obicetrapib to become a valuable addition to existing treatment options for ASCVD.
Michael Davidson, CEO of New Amsterdam Pharma, expressed optimism about obicetrapib’s potential to become a preferred therapy for lowering cardiovascular risk in conjunction with statin therapy. He highlighted the drug’s oral, once-daily administration, low dose, and ability to lower Lp(a) and small LDL particles as key differentiators. He also noted the potential for improving glycemic measures, though this aspect requires further investigation.
New Amsterdam Pharma plans to present comprehensive data from the BROADWAY trial and the parallel Phase III TANDEM trial at upcoming scientific conferences in 2025. The company also intends to engage with regulatory authorities to pursue approval for obicetrapib as a novel LDL-C lowering therapy. This promising treatment holds the potential to significantly impact the management of cardiovascular disease, offering new hope for patients at high risk.
